Symptoms and General Pathology

All Conditions

Neoplasms

Weight Loss

Head and Neck Neoplasms

Body Weight

Body Weight Changes

12 weeks progressive resistance training (PRT) during and after concomitant chemoradiotherapy. Also optional/voluntary physical activity performed on their own is registered, as well as diet diary.

Control arm. Optional/voluntary physical activity performed on their own is registered, as well as diet diary.

12 weeks supervised resistance training program. Details of the program: 12 weeks, 3 sessions per week, 7 exercises in training machines (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand)

Progressive Resistance Training

Weekly diary of performed physical activity using the Physical Activity Score (PAS) during the 12-weeks intervention

physical activity

Weekly diet diary during the 12-weeks intervention

Diet diary

Julie Gehl

72 patients with head and neck cancer, undergoing primary treatment with radiation therapy and concomitant weekly cisplatin, will be recruited to this multicentre trial.

Randomized 1:1 to either 12-week progressive resistance training (PRT) program or control arm, starting together with concomitant chemoradiotherapy (CCRT) Stratified by centre, gender, p16-status and body mass index (BMI) below or above 30.

Primary endpoint is difference in change in lean body mass (LBM) between the groups and the endpoint is reduction of LBM loss in intervention arm by 25% compared to control.

Secondary endpoints include side-effects to treatment, change in body composition, physical function and strength, and compliance to PRT. Questionnaires on QoL, diet, voluntary exercise and work affiliation will also be registered.

Blood samples for explorative analyses will be drawn and optional muscle biopsies drawn for proteomics analyses and histological analyses.

The PRT program will start about the onset of radiotherapy. The program consists of 7 exercises in training machines and involves the major muscle groups of the body.

The program has previously been found to successfully restore the loss of lean body mass (LBM) in head and neck cancer patients post-treatment. A group based approach will be used to facilitate a social and motivating training environment for the patients. A pilot study (NCT02068950) showed feasibility of PRT during CCRT.

In addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered: Weight, patient reported side effects, as well as a questionnaire on amount of physical activity and food intake.

Physical function and strength will be tested at baseline, after the course of chemoradiotherapy and at the end of the 12-week PRT programme, and at 6 and 12 months follow-up. DXA scans for body composition will be performed using a Lunar iDXA (GE Healthcare).

Blood samples will be drawn at regular intervals during the 12 weeks and at follow-up.

Patient reported quality of life (EORTC Quality of Life Questionnaire (QLQ)-C30 and QLQ-H\&N35) will also be registered.

Muscle biopsies will be taken three times: at baseline, after treatment and after 12-weeks PRT.

Study duration is expected to be 18 months and an additional 12 months for follow-up.

Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy

Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy - The DAHANCA 31 Study

measured by PAS (physical activity scale)

No. of days from end of radiotherapy until back at work at full time (or the hours of work per week as before therapy)

Percent of patients having relapse within 12 months after radiotherapy

Measurement of different cytokines, changes over time and after bout of PRT. Will be measured regularly during the 12 weeks of PRT.

protein will be measured using the proteomic approach. Muscle fiber type and size will be evaluated.

Study specific questionnaire regarding pros and cons of attending the study

Measuring NK-cells. NK-cells may increase after exercise and show tumor inhibiting effect.

Aarhus University Hospital

Odense University Hospital

Danish Head and Neck Cancer Group

Herlev Hospital

M.D., Dr. Med. Sci.

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Other Dietary Supplements

All Drugs and Chemicals

Amino Acids

Omega 3 Fatty Acid

Arginine

The immunomodulating oral supplementation compound (Oral Impact®) contains 334kcal/bag and 18.1g of proteins, as well as immunomodulatory nutrients such as L-Arginine, RNA and omega-3.

Each bag of product containing powder (74g/bag) will be diluted in 250 millilitres of water by the patients and drunk at home. Three doses will be drunk at home by the patients daily, during the 5 days before each chemotherapy cycle.

The control has the same formula to that of the Oral Impact®, but not enriched with specific nutrients: it is an isocaloric isonitrogenous control.

Each bag of product containing powder (74g/bag) will be diluted in 250 millilitres of water by the patients and drunk at home. Three doses will be drunk at home by the patients daily, during the 5 days before each chemotherapy cycle.

Per os administration, 3 times / day, 5 days before each cycle of chemotherapy.

Immunomodulating oral supplementation

Sip feed control

Pierre SENESSE, MD

The investigators designed a prospective randomized double-blind trial to determine if the oral immunomodulating formula could improve the disease-free survival rate in high-risk locally-advanced head and neck Squamous Cell Carcinoma patients treated with Chemoradiotherapy.

The primary objective is to evaluate the efficacy on disease-free survival of a formula enriched with L-arginine, omega-3 fatty acids, and ribonucleic acids, taken for 5 days before each cycle of chemotherapy, in patients with high-risk locally-advanced HNSCC treated with postoperative concomitant chemoradiotherapy (CRT).

This study is a national, multicentric double blinded, randomised phase III trial. A total of 306 patients (102 patients in group control vs 204 patients in group Oral Impact®) will be required including 10% of lost-to-follow-up patients.

An immunomodulating oral supplementation compound (Oral Impact®) is compared to an isocaloric isonitrogenous control. The compound to be assessed contains 334kcal/bag and 18.1g of proteins, as well as immunomodulatory nutrients such as L-Arginine, RNA and omega-3. The control has the same formula to that of the Oral Impact®, but not enriched with specific nutrients. Each patient has to take Oral Impact® or a sip feed control during 5 days before each cycle of chemotherapy.

DFS will be measured from the time of randomization to the time of the first evidence of progression (local, regional, metastatic, or second primary) or death from any cause. Patients alive without carcinologic event were censored at last follow-up date.

Patients treated with postoperative CRT are expected to have a 2-year DFS rate of 60% without specific diet (pControl).

Including a ratio 1:2, an expected recruitment of 90 patients per year, the current study will require 131 events to detect an absolute improvement of 15% (HR=0.56, pExperimental=75%) with 0.90 statistical power using a two-sided test and a significance level of 0.05.

A total of 306 patients (102 vs 204) will be required including 10% of lost of follow-up patients.

The inclusion period would be 4 years, for an expected total duration of study about 8 years.

Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Cancer

Double-blind Multicenter Phase III Trial Evaluating the Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC)

the compliance is defined as the taking of more than 75 % of study product prescription

The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.

The EORTC HN35 uses a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

Cachexia will be evaluated with weight (in kilograms)

Institut du Cancer de Montpellier - Val d'Aurelle

Rare Diseases

Hypopharyngeal Cancer

Antineoplastic Agents

Capecitabine

Docetaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Patients initially receive induction chemotherapy consisting of docetaxel, cisplatin and capecitabine (TPC), q3w, 2-3 cycles in total.

Patients with regional response of complete reaction (CR)/partial reaction (PR)≥50% after induction chemotherapy then receive concomitant chemoradiotherapy for both the primary and regional sites.

Patients with regional response of PR\<50%/stable disease (SD)/progressive disease (PD) after induction chemotherapy then receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy.

Patients initially receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy.

Radiotherapy: using intensity-modulated radiation therapy (IMRT)

Gross tumor volume (GTV) for primary tumor: 66-70 Gy in total, 2.0\~2.2 Gy per day, 5 days per week

Clinical target volume (CTV) for lesions closely related to the primary lesion and metastatic lymph nodes: 65\~70 Gy in total, 1.7\~2.0 Gy per day, 5 days per week

Prophylactic irradiation for sites of suspected subclinical spread: 50\~60 Gy in total, 1.7\~2.0 Gy per day, 5 days per week

Concurrent chemotherapy: cisplatin 80 mg/m2 on days 1-3 every 3 weeks.

Concomitant chemoradiotherapy

Neck dissection and primary tumor resection

Surgery

Feiran Li

Susheng Miao, PhD

Zhenghua Lv, PhD

Ming Zhang, PhD

This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.

Hypopharyngeal squamous cell carcinoma (HPSCC) is prone to have regional metastasis, which is an established negative prognostic factor. Especially for N2/3 patients whose metastatic neck nodes are bulky and have multiple or extracapsular spreads, their survival outcome is even worse. Therefore, it is vital for clinicians to select proper treatment and further improve the prognosis of N2/3 HPSCC patients. The aim of this randomized controlled prospective study is to explore the suitable treatment strategy of metastatic neck nodes in N2/3 HPSCC. This study will enroll a total of 111 HPSCC patients, who are clinically classified as T1/2 N2/3 M0 stage and initially treated with surgery (group 1) or induction chemotherapy (group 2). For patients with the regional response of PR\<50%/SD/PD after induction chemotherapy, their following treatment will be surgery for both the primary and regional sites. For patients with the regional response of CR/PR≥50%, the following treatment will be concomitant chemoradiotherapy for both the primary and regional sites.

The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma

The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma: A Multi-center Randomized Controlled Prospective Study

The proportion of patients with disease progress or death due to any reasons.

The proportion of dead patients due to any reasons.

The proportion of patients with local recurrence.

The proportion of patients with regional recurrence.

The proportion of patients with distant metastasis.

Evaluated by University of Washington Quality of Life Questionnaire (UW-QOL) V4.0.

Evaluated by the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy	NCT02557529	Head and Neck N... Weight Loss	Progressive Res... physical activi... Diet diary	18 Years -	Herlev Hospital
Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Cancer	NCT04001543	Head and Neck S...	Immunomodulatin... Sip feed contro...	18 Years - 75 Years	Institut du Cancer de Montpellier - Val d'Aurelle
Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy	NCT02557529	Head and Neck N... Weight Loss	Progressive Res... physical activi... Diet diary	18 Years -	Herlev Hospital
The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma	NCT05494190	Hypopharyngeal ...	Docetaxel Cisplatin Capecitabine Concomitant che... Surgery	18 Years - 75 Years	Eye & ENT Hospital of Fudan University
Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Cancer	NCT04001543	Head and Neck S...	Immunomodulatin... Sip feed contro...	18 Years - 75 Years	Institut du Cancer de Montpellier - Val d'Aurelle
The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma	NCT05494190	Hypopharyngeal ...	Docetaxel Cisplatin Capecitabine Concomitant che... Surgery	18 Years - 75 Years	Eye & ENT Hospital of Fudan University
Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Cancer	NCT04001543	Head and Neck S...	Immunomodulatin... Sip feed contro...	18 Years - 75 Years	Institut du Cancer de Montpellier - Val d'Aurelle
Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy	NCT02557529	Head and Neck N... Weight Loss	Progressive Res... physical activi... Diet diary	18 Years -	Herlev Hospital

Spots Global Cancer Trial Database for concomitant chemoradiotherapy